Clinical Trials for Uterine Cancer

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic HR+/HER2- breast cancer, squamous head and neck, urothelial, or endometrial cancers harboring PIK3CA mutations or amplifications, who have not previously received PI3K, AKT, or mTOR inhibitors. Patients receive TOS-358, a first-in-class, covalent, and selective PI3Kα inhibitor, administered orally as a single agent.

ClinicalTrials.gov ID: NCT05683418

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial is enrolling adults with advanced, unresectable, or metastatic solid tumors harboring PIK3CA (PI3Kα) mutations, including HR+ breast, gynecologic, endometrial, and head and neck cancers, to receive the investigational orally administered mutant-selective PI3Kα inhibitor STX-478 as monotherapy or in combination with standard endocrine and CDK4/6 inhibitors. Eligible patients must have ECOG 0-1 and adequate organ function; those with uncontrolled diabetes or symptomatic CNS metastases are excluded.

ClinicalTrials.gov ID: NCT05768139

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic PIK3CA-mutated solid tumors—including HR+ HER2- breast cancer and endometrial cancer—to receive the mutant-selective PI3Kα inhibitor RLY-2608 (oral, allosteric, isoform- and mutant-specific) as monotherapy or in combination with fulvestrant, CDK4/6 inhibitors, or the investigational CDK4-only inhibitor PF-07220060. Eligible patients include those who are refractory or intolerant to standard therapies, including prior endocrine and CDK4/6 inhibitor treatments.

ClinicalTrials.gov ID: NCT05216432

A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced, recurrent, or metastatic solid tumors (including breast, endometrial, and ovarian cancers) who have progressed on standard therapy and meet eligibility criteria are treated with XMT-1660, a B7-H4-targeted antibody-drug conjugate delivering an auristatin payload to B7-H4-positive tumor cells. Prior B7-H4 therapy or auristatin ADCs, untreated CNS metastases, and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT05377996

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT04485013

Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH Trial)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic HER2-expressing solid tumors—particularly colorectal and gastroesophageal cancers after progression on standard therapy—and evaluates intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate) in combination with oral ceralasertib (a selective ATR kinase inhibitor targeting DNA damage response pathways).

ClinicalTrials.gov ID: NCT04704661

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls children, adolescents, and young adults with recurrent or refractory solid tumors (including lymphomas and desmoid tumors), treating them with intravenous tegavivint, a small molecule inhibitor targeting TBL1 to disrupt Wnt/beta-catenin signaling. Expansion cohorts focus on specific tumor types and Wnt pathway–driven malignancies.

ClinicalTrials.gov ID: NCT04851119

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors, including biomarker-selected cohorts (e.g., ATM loss/alterations; platinum‑resistant high‑grade serous ovarian cancer; selected endometrial, colorectal, and pancreatic cancers), after appropriate standard therapies. Investigational therapy is ART0380, an oral ATR kinase inhibitor exploiting replication-stress/synthetic lethality, given as monotherapy or combined with gemcitabine or irinotecan; includes a randomized cohort of platinum‑resistant ovarian cancer comparing ART0380+gemcitabine versus gemcitabine.

ClinicalTrials.gov ID: NCT04657068